Domestic and International Cosmetic Tourism Complications Presenting to a U.S. Tertiary Hospital.

BACKGROUND: Cosmetic surgery tourism has become a significant global industry. Oftentimes, patients who develop postoperative complications present for care in their home U.S. state. OBJECTIVES: This study evaluated patients who either traveled abroad or to other states within the United States for cosmetic surgeries and returned with complications treated in the authors' center. We sought to compare rates of complications between patients that underwent cosmetic surgery internationally and domestically. METHODS: This retrospective cross-sectional study reviewed patients who presented from June 2014 to June 2022 with concerns related to cosmetic surgeries performed in another state or abroad. Binary logistic regressions were performed to assess differences in outcomes between domestic and international cases, including complications, interventions, and admissions. RESULTS: One-hundred twenty-three patients (97.6% female, me an age 34.0 ± 8.7 years, range 16-62 years) comprised 159 emergency department consultations. The most common procedures included abdominoplasty (n=72) and liposuction (n=56). Complications included wound dehiscence (n=39), infection (n=38), and seroma (n=34). Over one-half of patients required intervention. Twenty-nine patients (23.6%) required hospital admission. On multivariate regression analyses, incidence of seroma (p=0.025) and oral (p=0.036) and intravenous antibiotic prescriptions (p=0.045) were significantly greater among the international cohort compared to domestic, whereas all other complication variables were non-significant. There were no other significant differences in operative interventions or hospital admissions between international and domestic cohorts. CONCLUSIONS: Compared to domestic tourism cases, international tourism cases were associated with significantly higher rates of seroma formation and antibiotic use. There were no significant differences otherwise in overall complications including infections, operative interventions, or hospital admissions.

A scoping review of vasculitis as an immune-related adverse event from checkpoint inhibitor therapy of cancer: Unraveling the complexities at the intersection of immunology and vascular pathology.

BACKGROUND/PURPOSE: Vasculitis as an immune-related adverse event (irAE) from checkpoint inhibitor therapy (ICI) to treat cancer is a rare clinical event, and little is known regarding its nosology, clinical manifestations, or response to treatment and outcomes. METHODS: To address these gaps, we used the Preferred Reporting Items for Systemic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) framework to further define this complication. Two independent PUBMED searches in September and November of 2022 revealed 127 publications with 37 excluded from title by relevance, 43 excluded by article type, and 23 excluded due to lack of biopsy results, or biopsy negative for vasculitis. Twenty-nine documented cases from 24 publications were included for final analysis. Basic demographics, ICI details, timing of onset of vasculitis symptoms, irAE treatment and outcomes were collected. The vasculitides were classified using 2022 ACR/EULAR Vasculitis Classification Criteria as well as 2012 Revised Chapel-Hill Nomenclature. Adaptations from Naidoo et al. 2023 [1] consensus definitions for irAEs were used and efforts were made to classify steroid-responsive versus unresponsive irAEs. RESULTS: Of the 29 cases reviewed, the average age of patients was 62.1 ± 11.0, composed of 58.6 % (n = 17) male and 41.3 % (n = 12) female. Prominent cancer types were lung cancer (41.4 %; n = 12), melanoma (41.4 %; n = 12), and renal cancer (10.3 %; n = 3), with majority being stage 4 (75.9 %, n = 22) and stage 3 (10.3 %, n = 3). Only 8 cases met the ACR/EULAR criteria, and by Chapel-Hill Nomenclature, approximately a third were small-vessel vasculitis (31.0 %; n = 9) with n = 4 positive for ANCA. Most biopsies were taken from the skin (37.9 %, n = 11) and kidney (24.1 %, n = 7). Patients were either treated with single (65.5 %, n = 19), dual (17.2 %; n = 5), or sequential (17.2 %; n = 5) ICI regimen which included anti-PD-1 therapy in all but one case, with mean of 8.7 ± 10.5 cycles received. Mean time to onset of symptoms from start of ICI was 7.2 ± 7.8 months, with 55.2 % occurring >3 months since the initial immunotherapy. Vasculitis treatment included glucocorticoids in 96 % of cases and immunotherapy was often discontinued (44.8 %; n = 13). Clinical improvement of irAE was documented in 86.2 % (n = 25). Data were missing in terms of fate of ICI (34.5 %; n = 10) and tumor outcomes (41.4 %; n = 12). Cancer progressed in 20.7 % (n = 6), stable in 34.5 % (n = 10) cases, and 6 patients died of all-causes. CONCLUSION: Vasculitis as an irAE appears clinically heterogeneous and rare. Among reported cases with adequate documentation, vasculitis is of delayed onset following the initiation of immunotherapy. Outcomes of ICI-vasculitis were generally favorable, responding to glucocorticoids and immunotherapy withdrawal. There is an urgent need for more standardized reporting of rare irAEs such as vasculitis to clarify clinical risks, classification, relationship to immunotherapy and outcomes.

Neoadjuvant Dual Checkpoint Inhibitors vs Anti-PD1 Therapy in High-Risk Resectable Melanoma: A Pooled Analysis.

Importance: Despite the clear potential benefits of neoadjuvant therapy, the optimal neoadjuvant regimen for patients with high-risk resectable melanoma (HRRM) is not known. Objective: To compare the safety and efficacy of dual checkpoint inhibitors with anti-programmed cell death protein-1 (anti-PD1) therapy in a neoadjuvant setting among patients with HRRM. Design, Setting, and Participants: In this pooled analysis of clinical trials, studies were selected provided they investigated immune checkpoint inhibitor treatment, were published between January 2018 and March 2023, and were phase 1, 2, or 3 clinical trials. Participant data included in the analysis were derived from trials evaluating the efficacy and safety of anti-PD1 monotherapy and the combination of anti-cytotoxic T lymphocyte-associated protein-4 with anti-PD1 in the neoadjuvant setting, specifically among patients with HRRM. Interventions: Patients were treated with either anti-PD1 monotherapy; dual checkpoint inhibition (DCPI) with a conventional dose of 3-mg/kg ipilimumab and 1-mg/kg nivolumab; or DCPI with an alternative-dose regimen of 1-mg/kg ipilimumab and 3-mg/kg nivolumab. Main Outcomes and Measures: The main outcomes were radiologic complete response (rCR), radiologic overall objective response (rOOR), and radiologic progressive disease. Also, pathologic complete response (pCR), the proportion of patients undergoing surgical resection, and occurrence of grade 3 or 4 immune-related adverse events (irAEs) were considered. Results: Among 573 patients enrolled in 6 clinical trials, neoadjuvant therapy with DCPI was associated with higher odds of achieving pCR compared with anti-PD1 monotherapy (odds ratio [OR], 3.16; P < .001). DCPI was associated with higher odds of grade 3 or 4 irAEs compared with anti-PD1 monotherapy (OR, 3.75; P < .001). When comparing the alternative-dose ipilimumab and nivolumab (IPI-NIVO) regimen with conventional-dose IPI-NIVO, no statistically significant difference in rCR, rOOR, radiologic progressive disease, or pCR was noted. However, the conventional-dose IPI-NIVO regimen was associated with increased grade 3 or 4 irAEs (OR, 4.76; P < .001). Conventional-dose IPI-NIVO was associated with greater odds of achieving improved rOOR (OR, 1.95; P = .046) and pCR (OR, 2.99; P < .001) compared with anti-PD1 monotherapy. The alternative dose of IPI-NIVO also was associated with higher odds of achieving rCR (OR, 2.55; P = .03) and pCR (OR, 3.87; P < .001) compared with anti-PD1 monotherapy. The risk for grade 3 or 4 irAEs is higher with both the conventional-dose (OR, 9.59; P < .001) and alternative-dose IPI-NIVO regimens (OR, 2.02; P = .02) compared with anti-PD1 monotherapy. Conclusion and Relevance: In this pooled analysis of 6 clinical trials, although DCPI was associated with increased likelihood of achieving pathological and radiologic responses, the associated risk for grade 3 or 4 irAEs was significantly lower with anti-PD1 monotherapy in the neoadjuvant setting for HRRM. Additionally, compared with alternative-dose IPI-NIVO, the conventional dose of IPI-NIVO was associated with increased risk for grade 3 or 4 irAEs, with no significant distinctions in radiologic or pathologic efficacy.

Anterior and superior plate positions in diaphyseal clavicle fractures produce similar patient outcomes.

PURPOSE: While diaphyseal clavicle fractures can be treated with plate fixation on either the superior or anteroinferior aspect of the clavicle, the optimal plate position remains controversial. The purpose of this study was to determine if anteroinferior vs. superior plating for clavicle fracture fixation leads to better patient outcomes. METHODS: A retrospective review of patients who sustained clavicle fractures (OTA/AO 15.2) treated with superior or anteroinferior plating at a tertiary Level I trauma center from 2015 to 2021 was performed. The clinical outcomes of clavicle fractures were compared between groups treated with an anterior versus a superior approach via Mann-Whitney U and Chi-squared tests as appropriate to evaluate for differences in outcomes between the two plate positions. RESULTS: A total of 315 diaphyseal clavicle fractures were identified. One hundred and forty patients were excluded due to inadequate follow-up. Of the remaining 175 patients, 25 were treated with an anteroinferior approach (14%) and 150 were treated with a superior approach (86%). There were no differences in age, BMI, tobacco use, or substance use between the two groups (p > 0.05 for all). On univariate analysis, there was no difference in rate of union (p = 0.60), nerve injury (p = 0.60), infection (p = 1.0), implant-related irritation (p = 0.42), implant removal (p = 0.26), or revision (p = 1.0) based on approach. Contoured plates had an association with risk of nerve injury (p = 0.04). CONCLUSION: There are no differences in union, nerve injury, infection, symptomatic implant, or revision rate between anteroinferior and superior clavicle approaches. Plate positioning during diaphyseal clavicle fracture fixation can reasonably be dictated based on surgeon preference and ideal reduction quality.

Initial experiences using plasma rich in growth factors to treat keratoneuralgia.

Keratoneuralgia, a clinical diagnosis of sensitized corneal pain without visible ocular surface damage, generally has minimal response to conventional therapies. Causes include refractive surgery and chronic dry eye. We evaluated the efficacy of Plasma Rich in Growth Factors (PRGF), a novel treatment prepared using a commercially available kit, in patients with keratoneuralgia. A retrospective chart review identified patients who had the clinical diagnosis of keratoneuralgia and were treated with PRGF for at least 3 months from October 2015 to April 2020 at a single academic institution. Both objective eye exam findings and concurrent treatments were obtained at baseline, 3 months, and final visit (if available). A questionnaire was administered to identified patients, including symptoms scores measured with a visual analog scale. The results of this survey and other objective findings were compared before and after PRGF treatment. 16 out of 32 patients (50%) with a mean follow-up period of 33 ± 26 months answered the questionnaire. Refractive surgeries were the cause of keratoneuralgia in 14 patients (87.5%), with LASIK the most common procedure (11 patients, 69%). There were no adverse events recorded or reported. Symptom scored by VAS in a modified Symptoms Assessment in Dry Eye questionnaire significantly decreased after PRGF use (85 ± 16 to 45 ± 33, p = 0.0002). Ten patients (63%) reported PRGF is superior to other therapy and would recommend to others. There were no significant trends in visual acuity, objective exam findings, or concurrent treatments after PRGF treatment. PRGF is safe and can potentially alleviate symptoms in patients with keratoneuralgia, a rare but devastating complication after refractive surgery. Prospective trial is indicated to explore PRGF as a potentially useful treatment for keratoneuralgia.

Anorectal pathology in the HIV population: a guide for radiologists.

Patients with human immunodeficiency virus (HIV) can present with a wide range of different acute and chronic pathologies. Anorectal conditions are particularly common in this unique patient population, including pathologies, such as proctitis, anorectal abscess, anorectal fistula, and anal squamous cell carcinoma. The radiologist plays a critical role in the assessment of these common forms of anorectal disease, as these conditions can present with various findings on imaging assessment. Pelvic CT, MRI, and FDG-PET/CT are among the most common modalities used for assessment of anorectal disease in the HIV patient population. Knowledge of the fundamental clinical and imaging findings associated with these pathologies in HIV patients is critical for radiologists.

Clinically Significant Prostate Cancer Detection After a Negative Prebiopsy MRI Examination: Comparison of Biparametric Versus Multiparametric MRI.

BACKGROUND. The frequency of clinically significant prostate cancer (csPCa) following negative biparametric MRI (bpMRI) and multiparametric MRI (mpMRI) has not been well investigated in direct comparative studies. OBJECTIVE. The purposes of this study were to compare the frequency of csPCa after negative prebiopsy bpMRI and mpMRI and to evaluate factors predictive of csPCa in the two cohorts. METHODS. This retrospective study included 232 men (mean age, 64.5 years) with negative bpMRI from August 2017 to March 2020 and 193 men (mean age, 69.0 years) with negative mpMRI from January 2018 to December 2018. PI-RADS category 1 or 2 was defined as negative. The study institution offered bpMRI as a low-cost self-pay option for patients without insurer coverage of prebiospy mpMRI. Patient characteristics and subsequent biopsy results were recorded. CsPCa was defined as Gleason score of 3 + 4 or greater. Multivariable regression analyses were performed to identify independent predictors of csPCa. The AUC of PSA density (PSAD) for csPCA was computed, and the diagnostic performance of PSAD was assessed at a clinically established threshold of 0.15 ng/mL2. RESULTS. Systematic biopsy was performed after negative bpMRI for 41.4% (96/232) of patients and after negative mpMRI for 30.5% (59/193) (p = .02). Among those undergoing biopsy, csPCa was present in 15.6% (15/96) in the bpMRI cohort versus 13.6% (8/59) in the mpMRI cohort (p = .69). The NPV for csPCa was 84% (81/96) for bpMRI and 86% (51/59) for mpMRI. In multivariable analyses, independent predictors of csPCa included smaller prostate volume (OR, 0.27; p < .001) and greater PSAD (OR, 3.09; p < .001). In multivariable models, bpMRI (compared with mpMRI) was not independently predictive of csPCa (p > .05). PSAD had an AUC for csPCa of 0.71 (95% CI, 0.56-0.87) in the bpMRI cohort versus 0.68 (95% CI, 0.42-0.93) in the mpMRI cohort. For detecting csPCa, a PSAD threshold of 0.15 ng/mL2 had NPV of 90% and PPV of 28%, in the bpMRI cohort versus NPV of 92% and PPV of 44% in the mpMRI cohort. CONCLUSION. The frequencies of csPCa were not significantly different at systematic biopsy performed after negative bpMRI and mpMRI examinations. PSAD had similar diagnostic utility for csPCa in the two cohorts. CLINICAL IMPACT. Either bpMRI or mpMRI, in combination with PSAD measurement, can help avoid negative prostate biopsies.

Outcomes of corneal neurotisation using processed nerve allografts: a multicentre case series.

BACKGROUND: Corneal neurotisation is a rapidly evolving procedure treating neurotrophic keratopathy. The variety of surgical techniques used and corresponding outcomes after corneal neurotisation are not well understood. This study describes the techniques and outcomes in the largest case series of corneal neurotisation using processed nerve allografts to date. METHODS: This is a retrospective case series of patients who underwent corneal neurotisation with human cadaveric processed nerve allografts. All patients had preoperative and postoperative description of best corrected visual acuity and measurement of corneal sensation. Comparative studies after stratification of techniques were performed. RESULTS: A total of 17 patients were identified. The cause of corneal anaesthesia was prior infection in eight cases, trigeminal nerve palsy in eight cases and ocular trauma in one case. There were no intraoperative or postoperative complications. Following neurotisation surgery, the time to first gain of corneal sensation and maximal gain of sensation occurred at a mean of 3.7 months (range 1-8 months) and 6.6 months (range 3-15 months), respectively. The mean preoperative and postoperative corneal sensation as measured by Cochet-Bonnet aesthesiometry was 0.36 cm (range 0-3.2 cm) and 4.42 cm (range 0-6 cm), respectively (p<0.01). Visual acuity was unchanged after neurotisation. There were no statistical differences in outcomes based on end-to-end versus end-to-side coaptations, donor nerve selection or laterality of donor nerve. CONCLUSION: Corneal neurotisation with processed nerve allografts is a safe and effective procedure. This study provides further evidence for the use of processed nerve allografts for corneal neurotisation.

Factors Influencing Patient Satisfaction With Care and Surgical Outcomes for Total Hip and Knee Replacement.

INTRODUCTION: Although patient satisfaction with total joint arthroplasty has been a well-measured outcome, little is known about how preadmission and post-discharge care experiences affect patients' rating of satisfaction. OBJECTIVE: This work aimed to identify actionable factors associated with better ratings of overall care and surgical results. METHODS: A 36-item survey assessing care in the preoperative, perioperative, and post-discharge phases of care and across all phases was mailed to 7,031 patients who underwent primary unilateral elective total hip arthroplasty and total knee arthroplasty in 2018. Exploratory factor analysis identified 7 actionable domains. Stepwise logistic regression models identified domains associated with ratings of overall care and satisfaction with surgical outcome. RESULTS: Of the 3,026 (43%) patients who returned the survey; 2,814 (93%) rated their overall experience of care as very good or excellent and satisfaction with surgical results as ≥ 7 on a 10-point scale. In exploratory factor analysis, four factors predicted higher ratings of both overall care and surgical outcome: knowing what to do with symptoms and pain during recovery (factor 1), self-reported health (factor 3), knowing what to expect before surgery (factor 4), and shared decision making (factor 6). Coordinated information among providers (factor 2), home health experience (factor 5), and patient-provider relationships (factor 7) also predicted overall care ratings. CONCLUSION: Patient-centered quality improvement in total joint replacement care requires thinking of care across the entire episode, including before and after the hospital stay for surgery, in addition to perioperative care. The actionable factors identified from this study can be incorporated into total joint replacement care to improve patients' satisfaction with overall care and surgical results.

Accuracy of intraocular lens calculation formulas for flanged intrascleral intraocular lens fixation with double-needle technique.

PURPOSE: To evaluate the refractive prediction error (RPE) of intraocular lens (IOL) calculation formulas in eyes that have undergone the Yamane technique for scleral fixation of IOLs. SETTING: Alkek Eye Center, Cullen Eye Institute, Baylor College of Medicine, Houston, Texas. DESIGN: Retrospective case series from electronic chart review. METHODS: Patients who had undergone scleral fixation of secondary IOLs were selected. The IOL RPEs for 4 IOL prediction formulas-Barrett Universal II, Holladay 1, Hoffer Q, and SRK/T formulas-were obtained by subtracting the predicted spherical equivalent from the postoperative spherical equivalent. The arithmetic mean RPE, mean absolute error (MAE), and percentages of eyes with prediction error of 0.50 diopter (D) or lesser and 1.00 D or lesser were calculated and compared. RESULTS: Forty eyes of 40 patients met inclusion criteria. All formulas produced hyperopic mean arithmetic RPE. MAE values were 0.73 D for Holladay 1, 0.76 D for Barrett Universal II, 0.80 D for SRK/T, and 0.86 D for Hoffer Q formulas. The percentage of eyes with prediction error of 0.50 D or lesser and 1.00 D or lesser with these formulas were 45% (18 eyes) and 75% (30 eyes) for Holladay 1, 38.5% (15 eyes) and 77% (30 eyes) for Barrett Universal II, 32.5% (13 eyes) and 67.5% (27 eyes) for SRK/T, and 27.5% (11 eyes) and 62.5% (25 eyes) for Hoffer Q formulas. There were no statistically significant differences in prediction errors between the 4 formulas. CONCLUSIONS: Refractive outcomes of the Yamane technique were less predictable than those of standard cataract surgery. Arithmetic RPE ranged from hyperopic to predicted values for all formulas tested.

Assessing End-of-Life Care across Settings in an Integrated Health Care Delivery System.

Objective: To systematically capture patient- and family-centered data to understand variability and opportunities in end-of-life care delivery across settings in an integrated health care delivery system. Background: Improving the quality of end-of-life care requires assessing patient and family experiences across settings where care occurs, but we found no existing instrument suitable for this purpose. Methods: We conducted a cross-sectional survey with 10,308 surviving respondents (usually next of kin) of decedents in five Kaiser Permanente operating regions. The survey included eight items from an existing validated survey and three original items. Results: The overall response rate was 26% (2631). Most respondents reported that they were knowledgeable about decedents' end-of-life care and preferences. Across regions, 80% of respondents reported overall end-of-life care as excellent or very good. The proportion of excellent and very good responses was 74-84% across regions for items assessing attributes of end-of-life care, with statistically significant differences (p < 0.05). The proportion of positive responses was 69-89%. Overall, end-of-life care was rated as excellent or very good for a greater proportion of patients who received palliative care, hospice care, or both (78-82%), compared to those who did not (69%, p < 0.05 for all). Discussion: Regions are using data to inform end-of-life care initiatives. Assessing patient and family experiences of end-of-life care across settings with a single survey was feasible and provided valuable information supporting quality improvement. The survey met our need for a general purpose survey on end-of-life care experience.

Clinical Performance of Human Papillomavirus Testing and Visual Inspection With Acetic Acid in Primary, Combination, and Sequential Cervical Cancer Screening in China.

BACKGROUND: World Health Organization guidelines recommend screening with human papillomavirus (HPV) testing followed by either treatment of all HPV-positives, or by visual inspection (VIA) for triage to treatment, citing insufficient evidence to recommend either strategy over the other. METHODS: We assessed VIA and HPV testing individually, in combination (HPV-VIA cotesting), and as triage models. Three thousand women were screened in Inner Mongolia, China, concurrently with HPV testing and VIA in a real population setting. Screen-positive women underwent colposcopy, and biopsy, if indicated. Accuracy of screening algorithms for cervical intraepithelial neoplasia grade 2 or higher (CIN-2+) was calculated after controlling for verification bias. HPV testing followed by VIA triage for CIN-2+ detection was compared with Hybrid Capture 2 viral loads triage, measured in relative light units/cutoff. RESULTS: CIN-2+ prevalence was 1.0%. Corrected sensitivity, false negative rate, and specificity for CIN-2+, respectively, for primary HPV testing were 89.7%, 10.3%, and 83.3%; 44.8%, 55.2%, and 92·3% for VIA; 93.1%, 6.9%, and 80.2% for HPV-VIA cotesting; and 41.4%, 58.6, and 95.4% for HPV with VIA triage scenarios. Using relative light units/cutoff of 5 or greater to triage HPV-positive women had twice the sensitivity as VIA triage, with comparable specificity for CIN-2+. CONCLUSIONS: When VIA performs relatively poorly and HPV testing is available, adding VIA to sequential (ie, HPV followed by VIA triage) or primary (HPV-VIA cotesting) screening does not significantly improve CIN-2+ detection beyond primary HPV screening alone. Sequential screening (ie, HPV followed by VIA triage) reduces sensitivity too low for population-based screening programs. The HPV viral loads could offer an alternative low-resource country triage strategy.

Clustering patterns of type-type combination in multiple genotypes infections of human papillomavirus in cervical adenocarcinoma.

Coinfections with multiple types of human papillomavirus (HPV) occur in cervical adenocarcinoma (ADC). However, it remains unclear the clustering patterns of multiple types in HPV coinfections and relevant factors in ADC. A total of 718 paraffin-embedded ADC specimens were collected in China and tested for HPV genotypes using SPF10-INNO-LIPA. The prevalence of HPV coinfections and clustering patterns by geographical regions, histological subtypes and ages were assessed. Type-specific attribution of HPV to ADC adjusted by HPV coinfections were calculated. The prevalence of HPV coinfections was found to be 8.4% in ADC cases with slight variation by geographic regions between 2.2% and 12.5%. The 88.3% of all HPV multiple infections in ADC were two types of HPV coinfections with predominant combination of HPV 16 and HPV 18. The attribution to ADC was 88.0% for HPV 16/18 targeted by bivalent and quadrivalent vaccine and 96.8% for HPV 16/18/31/33/45/52/58 targeted by nonavalent vaccine. Clustering patterns of multiple types were related with histological categories and age at diagnosis. In conclusion, HPV coinfections are uncommonly prevalent in ADC cases with slight variation by geographic regions and distinct clustering patterns of multiple types by histological subtypes and ages at diagnosis. The high attribution of carcinogenic HPV types to ADC predicts potential protection of HPV vaccine against ADC.

Evaluation of menopausal status among breast cancer patients with chemotherapy-induced amenorrhea.

OBJECTIVE: In patients with chemotherapy-induced amenorrhea (CIA), the menopausal status is ambiguous and difficult to evaluate. This study aimed to establish a discriminative model to predict and classify the menopausal status of breast cancer patients with CIA. METHODS: This is a single center hospital-based study from 2013 to 2016. The menopausal age distribution and accumulated incidence rate of CIA are described. Multivariate models were adjusted for established and potential confounding factors including age, serum concentration of estradiol (E2) and follicle-stimulating hormone (FSH), feeding, pregnancy, parity, abortions, and body mass index (BMI). The odds ratio (OR) and 95% confidence interval (95% CI) of different risk factors were estimated. RESULTS: A total of 1,796 breast cancer patients were included in this study, among whom, 1,175 (65.42%) were premenopausal patients and 621 (34.58%) were post-menopause patients. Five hundred and fifty patients were included in CIA analysis, and a cumulative CIA rate of 81.64% was found in them. Age (OR: 1.856, 95% CI: 1.732-1.990), serum concentration of E2 (OR: 0.976, 95% CI: 0.972-0.980) and FSH (OR: 1.060, 95% CI: 1.053-1.066), and menarche age (OR: 1.074, 95% CI: 1.009-1.144) were found to be associated with the patients' menopausal status. According to multivariate analysis, the discriminative model to predict the menopausal status is Logit (P)=-28.396+0.536Age-0.014E2+0.031FSH. The sensitivities for this model were higher than 85%, and its specificities were higher than 89%. CONCLUSIONS: The discriminative model obtained from this study for predicting menstrual state is important for premenopausal patients with CIA. This model has high specificity and sensitivity and should be prudently used.

Risk of high-risk human papillomavirus infection and cervical precancerous lesions with past or current trichomonas infection: a pooled analysis of 25,054 women in rural China.

BACKGROUND: Trichomonas vaginitis (TV) infection has obviously been implicated in gynecological morbidity but still unclear in cervical lesions. OBJECTIVE: To evaluate the risk of hr-HPV infection and cervical intraepithelial neoplasia grade 2 or worse (CIN2 + ) by TV infection. STUDY DESIGN: The pooled study was conducted among 12 population-based, cervical cancer screening studies throughout China (N = 24,054). HPV was detected by Hybrid Capture®2 (HC2) test. Past TV infection was measured by self-reporting, current TV infection was diagnosed by liquid-based cytology (LBC), cervical lesions was diagnosed by histopathology. RESULTS: Respective prevalence of hr-HPV and CIN2+ were 17.4% and 3.3%. Out of 24,054 women, 14.6% reported past TV infection, and out of 11,853 women, 9.9% had current TV infection. Current TV-positive women had an increased risk for hr-HPV (OR 1.31, 95%CI: 1.11-1.56). The risk of CIN2+ decreased for hr-HPV positive women with current TV infection (adjusted OR 0.50, 95% CI: 0.30-0.84) and past TV infection (adjusted OR 0.68, 95% CI: 0.54-0.86). Among hr-HPV negative women, no significant associations were observed between past or current TV infection and risk of CIN2+. CONCLUSIONS: Women infected with HPV are more likely to be infected by other types of sexually transmitted diseases. Current TV-positive women had an increased risk for hr-HPV infection compared to currently TV-negative women. Both past and current TV-positive women had a decreased risk for CIN2+, especially among high-risk HPV positive women. More direct investigation into the interaction between TV, HPV, inflammatory signals, and risk of carcinogenesis are further needed.

Human papillomavirus viral load as a useful triage tool for non-16/18 high-risk human papillomavirus positive women: A prospective screening cohort study.

OBJECTIVE: ASCCP cervical cancer screening guidelines recommend triaging high-risk human papillomavirus (hrHPV) positive women with cytology and genotyping, but cytology is often unavailable in resource-limited areas. We compared the long-term risk of cervical cancer and precancers among type-specific hrHPV-positive women triaged by viral load to cytology and visual inspection with acetic acid (VIA). METHODS: A cohort of 1742 Chinese women was screened with cytology, VIA, and Hybrid Capture 2 (HC2) test and followed for ten years. All HC2-positive samples were genotyped. Viral load was measured by HC2 relative light units/cutoff (RLU/CO). Ten-year cumulative incidence rate (CIR) of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) for type-specific hrHPV viral load was estimated using Kaplan-Meier methods. RESULTS: Baseline hrHPV viral load stratified by specific genotypes was positively correlated with prevalent cytological lesions. Ten-year CIR of CIN2+ was associated with cytological lesions and viral load. Among HPV 16/18-positive women, ten-year CIR of CIN2+ was high, even with normal cytology (15.3%), normal VIA (32.4%), viral load with RLU/CO<10 (23.6%) or RLU/CO<100 (33.8%). Among non-16/18 hrHPV positive women, ten-year CIR of CIN2+ was significantly stratified by cytology grade of atypical squamous cell of undetermined significance or higher (2.0% VS. 34.6%), viral load cutoffs at 10 RLU/CO (5.1% VS. 27.2%), at 100 RLU/CO (11.0% VS. 35.5%), but not by VIA (19.1% VS. 19.0%). CONCLUSIONS: Our findings support the guidelines in referring all HPV16/18 positive women to colposcopy and suggest triaging non-16/18 hrHPV positive women using viral loads in resource-limited areas where cytology screening was inaccessible.

Comparison of Efficacy and Complications of Cyclophotocoagulation and Second Glaucoma Drainage Device After Initial Glaucoma Drainage Device Failure.

PURPOSE: Compare intraocular pressure (IOP) control and complication rates of a second glaucoma drainage device (GDD) to diode transscleral cyclophotocoagulation (TSCPC) following failure of an initial GDD. PATIENTS AND METHODS: Eyes with 1 GDD that required a second GDD or TSCPC for glaucoma control were included. Exclusion criteria were a cyclodestructive procedure before initial GDD, no light perception vision, or follow-up <1 year. Failure was defined as ≥1 of (1) reoperation for lowering IOP; (2) explantation of second GDD; (3) persistent hypotony; (4) use of oral carbonic anhydrase inhibitor for lowering IOP in the study eye; or (5) loss of light perception. Reoperation for lowering IOP included additional GDD implantation or additional cyclodestruction, except if additional cyclodestruction was within 6 months of the initial session. RESULTS: A total of 75 eyes (35 in second GDD; 40 in TSCPC) were included (mean follow-up, 25.5 mo). Both procedures lowered IOP [-11.4 mm Hg (±13.6) for second GDD and -7.8 mm Hg (±11.8) for TSCPC groups] and decreased the number of IOP-lowering medications at the last visit. The second GDD group had significantly greater mean survival time [45.0 mo (±4.2)] than the TSCPC group [26.5 mo (±2.8)] but significantly more postoperative complications (60% of eyes) and non-IOP-related procedures (40% of eyes) than the TSCPC group (20% for postoperative complications and 18% for non-IOP-related procedures). CONCLUSIONS: Although both second procedures are efficacious in lowering IOP and number of IOP-lowering medications, TSCPC failed earlier, whereas a second GDD had significantly more complications.

An evaluation of clinical performance of FTA cards for HPV 16/18 detection using cobas 4800 HPV Test compared to dry swab and liquid medium.

BACKGROUNDS: Effective dry storage and transport media as an alternative to conventional liquid-based medium would facilitate the accessibility of women in the low-resource settings to human papillomavirus (HPV)- based cervical cancer screening. OBJECTIVE: To evaluate analytical and clinical performance of indicating FTA™ Elute Cartridge (FTA card) for the detection of HPV16/18 and cervical precancerous lesions and cancer compared to dry swab and liquid medium. STUDY DESIGN: Ninety patients with abnormal cytology and/or HPV infection were included for analysis. Three specimens of cervical exfoliated cells from each woman were randomly collected by FTA card, dry swab or liquid-based medium prior to colposcopy examination. The subsequent HPV DNA tests were performed on cobas 4800 HPV platform. RESULTS AND CONCLUSIONS: High-risk HPV (hrHPV) positivity rate was 63.3%, 62.2% and 65.6% for samples collected by FTA card, dry swab and liquid medium, respectively. The overall agreements and kappa values for the detection of hrHPV, HPV 16 and HPV 18 between FTA card and liquid-based medium were 88.9% (κ=0.76), 97.8% (κ=0.94) and 100% (κ=1.0),respectively; between FTA card and dry swab were 92.1% (κ=0.83), 94.5% (κ=0.87) and 100% (κ=1.0), respectively. The performances of hrHPV tested by FTA card, dry swab, and liquid-based medium for detecting CIN2+ were comparable in terms of the sensitivity and specificity. The specificity of detection of CIN2+ by HPV16/18 increased by approximately 40% compared to hrHPV for any medium albeit at cost of a moderate loss of sensitivity. Dry medium might offer an alternative to conventional liquid-based medium in the HPV-based cervical cancer screening program especially in low-resource settings but still needs further evaluation.

Prospective comparison of hybrid capture 2 and SPF10-LiPA for carcinogenic human papillomavirus detection and risk prediction of cervical cancer: a population-based cohort study in China.

OBJECTIVE: To investigate the extent of the cross-reactivity of hybrid capture 2 (HC2) assay and evaluate the potential effect of cross-reactivity on the long-term risk for cervical cancer and precancers. METHODS: Based on the Shanxi Province Cervical Cancer Screening Study-I (SPOCCS-I) cohort from 2005 to 2014 in Shanxi, China, SPF10-line probe assay (LiPA) was performed in all 598 HC2 positive and 300 random-selected HC2 negative cervical specimens. Ten-year cumulative incidence rate (CIR) of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) of these two tests was evaluated using Kaplan-Meier methods. Possible human papillomavirus (HPV) types to be cross-reacted by HC2 were also analyzed. RESULTS: The overall agreement between HC2 and SPF10-LiPA for detecting carcinogenic HPV was 73.27%. The highest 10-year cumulative risk of CIN2+ was observed in both HC2 positive and LiPA-carcinogenic HPV positive women (25.70%; 95% confidence interval [CI]=23.55%-27.91%), followed by HC2 positive but LiPA-non-carcinogenic HPV positive women (9.97%; 95% CI=8.57%-11.50%), HC2 negative but LiPA-carcinogenic HPV positive (2.56%; 95% CI=2.44%-2.70%) and HC2 positive but LiPA-HPV negative (1.85%; 95% CI=1.78%-1.92%) women. The proportion of cross-reactivity of HC2 with untargeted carcinogenic types was 8.9%, most of which were attributable to HPV26, 73, 82, 69, 71, 53, 11, 43, and 54. CONCLUSION: The noticeable high risk of CIN2+ in women infected with cross-reacted non-carcinogenic HPV and low risk in those with miss-to-detective carcinogenic HPV supported an overall good clinical performance of HC2 for a general cervical cancer screening.